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Philips Ultrasound LLC

United States·US-MF-000002237

Last updated September 17, 2026

Information

Country: United States
Address: 22100, Bothell Everett Highway, Bothell, United States
Website: n/a
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: n/a
PRRC Contact: Sunny Yi
EUDAMED SRN: US-MF-000002237
FDA FEI Number: 3017894900
DUNS Number: 063377717

Catalogue (455)

Page 1 of 10

Device	Model / Reference	Registries	Class	Status
Alturion Diagnostic Ultrasound System	795419	EUDAMED	Class IIa	Active
EPIQ Series Diagnostic Ultrasound System	K260123	FDA 510(k)	Class II	Active
EPIQ Series Diagnostic Ultrasound Systems	K260680	FDA 510(k)	Class II	Active
Qlab Quantification Software	K132165	FDA 510(k)	Class II	Active
Sparq Diamond Select System	795116	FDA UDI	Class II	Active
Transducer C9-3io	989605395612	FDA UDI	Class II	Active
XPERIUS Ultrasound System	989605452211	FDA UDI	Class II	Active
Transducer C8-4v	989605408153	FDA UDI	Class II	Active
EPIQ 5 Diamond Select Ultrasound System	795120	FDA UDI	Class II	Active
Transducer S12-4	989605361973	FDA UDI	Class II	Active
EPIQ 5 Diagnostic Ultrasound System	989605408541	FDA UDI	Class II	Active
Transducer 5.0 CW	989605440662	FDA UDI	Class II	Active
Transducer L12-5 38	989605428532	FDA UDI	Class II	Active
Transducer C9-4ec	300013145921	FDA UDI	Class II	Active
ClearVue 550 Diagnostic Ultrasound System	989605409201	FDA UDI	Class II	Active
ClearVue 650 Diagnostic Ultrasound System	989605414681	FDA UDI	Class II	Active
Transducer X7-2	989605463501	FDA UDI	Class II	Active
Clearvue 850 Diagnostic Ultrasound System	795226	FDA UDI	Class II	Active
Transducer 3D8-4	989605345333	FDA UDI	Class II	Active
Transducer S12-4	989605440782	FDA UDI	Class II	Active
063377717	063377717	FDA UDI	Class II	Active
QLAB Quantification Software	Release 10.7	FDA UDI	Class II	Active
Transducer C8-5	989605440822	FDA UDI	Class II	Active
EPIQ CVx Ultrasound Circular Edition	795122	FDA UDI	Class II	Active
EPIQ CVx Diagnostic Ultrasound System Circular Edition	795122	FDA UDI	Class II	Active
Transducer L12-4	989605418963	FDA UDI	Class II	Active
Affiniti CVx Diagnostic Ultrasound System	795190	FDA UDI	Class II	Active
Transducer S8-3	989605440752	FDA UDI	Class II	Active
Transducer L8-4	989605440812	FDA UDI	Class II	Active
EPIQ Elite Ultrasound Circular Edition	795125	FDA UDI	Class II	Active
Transducer L12-3	989605348243	FDA UDI	Class II	Active
Affiniti 70 Ultrasound System	795210	FDA UDI	Class II	Active
Transducer T6207	989605439242	FDA UDI	Class II	Active
Transducer S4-2	989605430222	FDA UDI	Class II	Active
Transducer L11-3	989605400513	FDA UDI	Class II	Active
Transducer C9-4	989605365023	FDA UDI	Class II	Active
iE33 Diagnostic Ultrasound System	8500-0082-01	FDA UDI	Class II	Active
Affiniti 30 Diagnostic Ultrasound System	989605457591	FDA UDI	Class II	Active
Transducer S12	989605362014	FDA UDI	Class II	Active
C5-2 transducer	989605439592	FDA UDI	Class II	Active
Transducer C8-4v	989803002685	FDA UDI	Class II	Active
Affiniti 70 Diagnostic Ultrasound System Circular Edition	795119	FDA UDI	Class II	Active
Sparq Ultrasound System	795090	FDA UDI	Class II	Active
Transducer C5-2	989605454101	FDA UDI	Class II	Active
Lumify Diagnostic Ultrasound System	795005	FDA UDI	Class II	Active
Transducer S4-1	989605364993	FDA UDI	Class II	Active
Affiniti 30 Diamond Select Ultrasound System	795121	FDA UDI	Class II	Active
EPIQ 5W Ultrasound System	795206	FDA UDI	Class II	Active
Qlab Quantification Software	989606710071	FDA UDI	Class II	Active
EPIQ CVxi Diagnostic Ultrasound System	795232	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Philips Medical Systems Nederland B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 31, 2025	Z-0883-2026	—	open, classified	Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
Sep 5, 2025	Z-1621-2026	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Sep 5, 2025	Z-1624-2026	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Sep 5, 2025	Z-1627-2026	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Sep 5, 2025	Z-1626-2026	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Sep 5, 2025	Z-1619-2026	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Sep 5, 2025	Z-1628-2026	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Sep 5, 2025	Z-1618-2026	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Sep 5, 2025	Z-1622-2026	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Sep 5, 2025	Z-1625-2026	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Sep 5, 2025	Z-1620-2026	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Sep 5, 2025	Z-1623-2026	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2352-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2406-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2379-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2395-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2359-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2351-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2398-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2397-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2407-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2409-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2354-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2383-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2381-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2403-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2377-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2390-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2389-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2371-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2394-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2380-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2363-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2374-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2401-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2356-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2386-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2372-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2357-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2348-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2369-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2366-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2392-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2385-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2382-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2370-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2376-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2404-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2396-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2362-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2350-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2368-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2358-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2349-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2365-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2400-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2361-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2367-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2388-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2391-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2346-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2408-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2399-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2384-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2355-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2414-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2378-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2375-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2405-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2412-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2353-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2413-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2360-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2387-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2410-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2347-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2393-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2364-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2411-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2402-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Z-2373-2025	—	open, classified	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
May 28, 2025	Z-2052-2025	—	open, classified	Ultrasound transducer devices were refurbished beyond their useful life.
May 28, 2025	Z-2067-2025	—	open, classified	Ultrasound transducer devices were refurbished beyond their useful life.
May 28, 2025	Z-2060-2025	—	open, classified	Ultrasound transducer devices were refurbished beyond their useful life.
May 28, 2025	Z-2058-2025	—	open, classified	Ultrasound transducer devices were refurbished beyond their useful life.
May 28, 2025	Z-2062-2025	—	open, classified	Ultrasound transducer devices were refurbished beyond their useful life.
May 28, 2025	Z-2061-2025	—	open, classified	Ultrasound transducer devices were refurbished beyond their useful life.
May 28, 2025	Z-2051-2025	—	open, classified	Ultrasound transducer devices were refurbished beyond their useful life.
May 28, 2025	Z-2054-2025	—	open, classified	Ultrasound transducer devices were refurbished beyond their useful life.
May 28, 2025	Z-2057-2025	—	open, classified	Ultrasound transducer devices were refurbished beyond their useful life.
May 28, 2025	Z-2064-2025	—	open, classified	Ultrasound transducer devices were refurbished beyond their useful life.
May 28, 2025	Z-2066-2025	—	open, classified	Ultrasound transducer devices were refurbished beyond their useful life.
May 28, 2025	Z-2068-2025	—	open, classified	Ultrasound transducer devices were refurbished beyond their useful life.
May 28, 2025	Z-2056-2025	—	open, classified	Ultrasound transducer devices were refurbished beyond their useful life.
May 28, 2025	Z-2048-2025	—	open, classified	Ultrasound transducer devices were refurbished beyond their useful life.
May 28, 2025	Z-2049-2025	—	open, classified	Ultrasound transducer devices were refurbished beyond their useful life.
May 28, 2025	Z-2055-2025	—	open, classified	Ultrasound transducer devices were refurbished beyond their useful life.
May 28, 2025	Z-2059-2025	—	open, classified	Ultrasound transducer devices were refurbished beyond their useful life.
May 28, 2025	Z-2050-2025	—	open, classified	Ultrasound transducer devices were refurbished beyond their useful life.
May 28, 2025	Z-2065-2025	—	open, classified	Ultrasound transducer devices were refurbished beyond their useful life.